- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01535716
Effects of a Goal-directed Hemodynamic Therapy Driven by ECOM on Morbidity and Mortality After Cardiac Surgery? (ECOMIII)
Does Goal-directed Hemodynamic Therapy Driven by Endotracheal Cardiac Output Monitoring System During Surgical Intervention Reduce Hospital Stay and Major Adverse Cardiac Events Following Cardiac Surgery?
Goal-directed hemodynamic and fluid optimizations are shown to be a key factor of the medical care during anesthesia.According to medical literature, goal-directed fluid and hemodynamic optimizations are more efficient when based on the dynamic parameters than when based on the statics ones, and the major dynamic criteria is the cardiac output. Unfortunately, transpulmonary thermodilution, the device considered as "The gold standard" to evaluate cardiac output is associated with many complications.Furthermore, devices commercialized in the past decade were not able to replace the transpulmonary thermodilution.
As all monitoring devices aren't reliable enough to be widely used in practice they are left aside in benefits of the clinical evaluation. Even though, hemodynamic optimization based on the analysis of several clinical parameters seems to guarantee good cares thanks to a favorable benefits/risks balance, it could be improved by new plug and play mini-invasive systems.
In the investigators opinion, the ECOM system seems able to provide a monitoring tool which responds to all the expectations of a modern hemodynamic monitoring device. It uses a well known technique, the bioimpedance. The investigators suppose this device should be more efficient than the one that has been used before. Indeed, as the system is build on the endotracheal tube, it comes closer to the aorta, where all the measures are made, and the recorded signal should be less affected by the passage through the surrounding tissues.
This randomized and controlled trial will study Patients scheduled for elective coronary surgery with cardiopulmonary bypass.
The purpose of this trial is to evaluate the benefits of an intraoperative goal-directed hemodynamic therapy based on the ECOM cardiac output measure on mortality and major postoperative cardiac morbidity after coronary surgery, when compared with a standard management strategy.
Patients will be allocated into control and ECOM groups, of 50 peoples each. The standard management strategy, applied to the control group, will be set and led by the attending anesthetist, based on the analysis of further clinical parameters. The ECOM Group will face the hemodynamic optimization strategy led by the ECOM evaluation of cardiac output and stroke volume variation.
The main hypothesis is that the hemodynamic strategy led by the ECOM cardiac output measure will reduce mortality and morbidity after cardiac surgery.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 4
Kontakte und Standorte
Studienorte
-
-
Calvados
-
Caen, Calvados, Frankreich, 14000
- University Hospital of Caen
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Any man or woman
- Over 18 year-old
- After obtaining written informed consent
- Scheduled for elective coronary surgery with CPB
Exclusion Criteria:
- Emergency surgery (< 24h)
- Combined cardiac surgery
- Patients < 18 years-old and/or unable to give informed consent
- Patients who refuse to give informed consent
- Pregnancy
- PVC allergy
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Fakultätszuweisung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: ECOM group
50 Patients scheduled for elective coronary surgery with cardiopulmonary bypass
|
goal directed hemodynamic therapy is based on the ECOM evaluation of stroke volume variation (SVV) & cardiac index (CI). goals:
During the anesthesia
Andere Namen:
|
Aktiver Komparator: standard management group
50 Patients scheduled for elective coronary surgery with cardiopulmonary bypass
|
goal directed hemodynamic therapy will be set and performed by the attending anesthetist, based on the analysis of further clinical parameters: Standard monitoring : heart rate, saturation index
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
length of hospital stay
Zeitfenster: Data collected at the exit of hospital or at death, if during hospital stay.patients will be followed for the duration of hospital stay, an expected average of 10 days. expected before 1 month
|
Data collected at the exit of hospital or at death, if during hospital stay.patients will be followed for the duration of hospital stay, an expected average of 10 days. expected before 1 month
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Number of major adverse cardiac events during stay in hospital
Zeitfenster: Data collected at the exit of ICU, at the exit of hospital or at death if during hospital stay.patients will be followed for the duration of hospital stay, an expected average of 10 days.Up to 1 month
|
Data collected at the exit of ICU, at the exit of hospital or at death if during hospital stay.patients will be followed for the duration of hospital stay, an expected average of 10 days.Up to 1 month
|
Length of stay in ICU
Zeitfenster: at the exit of ICU or at death, if during hospital stay.expected before 1 month
|
at the exit of ICU or at death, if during hospital stay.expected before 1 month
|
In-hospital mortality
Zeitfenster: at the end of the study. up to 12 month
|
at the end of the study. up to 12 month
|
Number of patients with Major adverse cardiac events during in-hospital stay.
Zeitfenster: at the end of the study. Up to 12 month
|
at the end of the study. Up to 12 month
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Studienleiter: Jean-Luc Fellahi, EA3212: groupe coeur et ischémie
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- 2011-A01210-41
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